ieCrowd recently announced the achievement of a crucial milestone in the commercial advancement of Smart Oxygen, the firm’s supplemental oxygen delivery device. Smart Oxygen is designed to be used by patients who require supplemental oxygen such as those suffering with advanced COPD.
The device is being advanced by ieCrowd’s subsidiary Smart Oxygen Solutions and has the ability to automatically adjust to the patient’s need for oxygen, even if those demands are constantly changing, through analyzing the level of activity.
The FDA announced that the 510 (k) submission for the Smart Oxygen device would need several technical bench and laboratory performance tests, but that no clinical study would have to be performed. This simplified submission, in comparison to a submission including clinical trials, corroborates the expected timeline in order to have Smart Oxygen Solutions commercially available in the first months of 2016. During a technical review meeting, the regulatory pathway was explained.
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